ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000270819

Ethics application status

Approved

Date submitted

5/03/2012

Date registered

6/03/2012

Date last updated

30/08/2024

Date data sharing statement initially provided

30/08/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

Zoledronate and fracture prevention in early postmenopausal women

Scientific title

Efficacy of very infrequent zoledronic acid on vertebral fractures and bone mineral density in early postmenopausal women

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Osteoporosis

Condition category

Condition code

Musculoskeletal

Osteoporosis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Arm 1: Intravenous infusion of 5mg zoledronic acid at baseline and an intravenous infusion of placebo (saline solution) at 5 years. (Total of two infusions during study)
Arm 2: Intravenous infusion of 5mg zoledronic acid at baseline and 5 years. (Total of two infusions during study)

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

Arm 3: Intravenous infusion of placebo (normal saline) at baseline and 5 years. (Total of two infusions during study)

Control group

Placebo

Outcomes

Primary outcome [1]

New morphometric vertebral fractures since baseline assessed using thoracic and lumbar spine plain x-rays

Timepoint [1]

Thoracic and spinal x-rays will be taken at baseline, 5 years, and 10 years in all participants.

Secondary outcome [1]

Change in bone mineral density from baseline measured at the spine, hip and whole body with dual enery x-ray absorptiometry

Timepoint [1]

Bone density will be measured at baseline, 5 years and 10 years in all participants, and in a subset of 225 participants at 2.5 years and 7.5 years.

Secondary outcome [2]

Incidence of any, fragility, and major osteoporotic fractures assessed using plain x-rays, CT or MRI imaging.

Timepoint [2]

10 years

Secondary outcome [3]

Change in bone turnover markers since baseline

Timepoint [3]

Bone turnover markers will be measured in a subset of 225 participants at baseline, 2.5 years, 5 years, 7.5 years and 10 years

Secondary outcome [4]

Equivalence of 5mg zoledronate administered using two different dosing intervals (either 5mg at baseline or 5mg at baseline and 5 years) in preventing new morphometric vertebral fractures since baseline assessed using thoracic and lumbar spine plain x-rays

Timepoint [4]

Thoracic and spinal x-rays will be taken at baseline, 5 years, and 10 years in all participants.

Secondary outcome [5]

Adverse events (including the expected adverse event of acute phase reactions)

Timepoint [5]

Medical history and adverse events will be assessed by interview at baseline, and every 6 months until 10 years. Assessments will be at a clinic visit at baseline, 5 years and 10 years, and by phone or email contact at other timepoints.

Eligibility

Key inclusion criteria

Postmenopausal women aged 50-60 years.
Bone mineral density T score at the lumbar spine, femoral neck or total hip < 0

Minimum age

50 Years

Maximum age

60 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Bone mineral density T score <-2.5 at the total hip, femoral neck or lumbar spine.
Renal impairment (estimated glomerular filtration rate > 45 ml/min).
Untreated hypothyroidism or hyperthyroidism.
Chronic liver disease.
Concurrent major systemic illness, including malignancy.
Active major gastrointestinal disease.
Metabolic bone diseases.
Previous fragility fracture of the hip or spine.
Current or past use of bisphosphonate therapy within 12 months, or past zoledronic acid use.
Use of oral glucocorticoid drugs equivalent to an average dose of at least prednisone 2.5mg/day during the preceding 6 months.
Use of hormone replacement therapy within 12 months

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Subject numbers will be allocated by personnel based in a different building and having no contact with study subjects. Infusions of study medication (zoledronate or placebo) will be prepared by a staff member who has no contact with the study subjects and no role in any other study procedures including assessments of end-points. All personnel having contact with study subjects and the subjects themselves will be blinded to treatment allocation.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer-generated random numbers in variable blocks

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/2012

Actual

22/05/2012

Date of last participant enrolment

Anticipated

Actual

5/08/2013

Date of last data collection

Anticipated

Actual

25/10/2023

Sample size

Target

1050

Accrual to date

Final

1054

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

Address: P.O. Box 5541
Wellesley St
Auckland 1141

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Dr Mark Bolland

Address

Bone and Joint Research Group,
Department of Medicine,
University of Auckland,
85 Park Road, Grafton
Private Bag 92019,
Auckland, 1142

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern X Regional Ethics Committee

Ethics committee address [1]

Private Bag 92522
Wellesley Street
Auckland 1141

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

07/12/2011

Ethics approval number [1]

NTX/11/11/097

Summary

Brief summary

Low bone density is a strong risk factor for fracture, but 80% of fractures occur in women without low bone density. We plan to investigate whether zoledronate, an effective osteoporosis treatment, can be given very infrequently by injection to prevent bone loss and spinal fractures in women with normal or only mildly low bone density. 
The proposed study is a prospective, randomised, double-blind, placebo-controlled, trial to be carried out over a period of ten years. 1050 post-menopausal women, aged 50-60 years, will be randomly assigned to receive either infusions of zoledronate or an inactive agent (placebo) at baseline and at five years. There will be three treatment groups- women who receive zoledronate at baseline and five years, women who receive zoledronate at baseline and placebo at five years, and women who receive placebo at baseline and five years. The main outcomes are occurrence of new spinal fractures and changes in bone density. Participants will have study visits every 5 years, and phone or email visits every six months, and at baseline, five years, and 10 years, participants will have a measurement of bone density and xrays of the spine.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Mark Bolland

Address

Bone and Joint Research Group, Department of Medicine, University of Auckland, 85 Park Road, Grafton Private Bag 92019, Auckland, 1142

Country

New Zealand

Phone

6493737599

Fax

m.bolland@auckland.ac.nz

Contact person for public queries

Name

Dr Anne Horne

Address

Bone and Joint Research Group,
Department of Medicine,
University of Auckland,
85 Park Road, Grafton
Private Bag 92019,
Auckland, 1142

Country

New Zealand

Phone

64 9 9239787

Fax

64 9 3072865

a.horne@auckland.ac.nz

Contact person for scientific queries

Name

Mark Bolland

Address

Bone and Joint Research Group,
Department of Medicine,
University of Auckland,
85 Park Road, Grafton
Private Bag 92019,
Auckland, 1142

Country

New Zealand

Phone

64 9 3737599

Fax

64 9 3737677

m.bolland@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

De-identified data underpinning published results

When will data be available (start and end dates)?

12 months after relevant publication with no end date determined

Available to whom?

Researchers who provided a protocol that is methodologically sound

Available for what types of analyses?

Analyses specified in the approved protocol

How or where can data be obtained?

By contacting the principal investigator (m.bolland@auckland.ac.nz)

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Intravenous zoledronate for osteoporosis: less might be more	2016	https://doi.org/10.1177/1759720x16650866
Dimensions AI	Bone Mineral Density and Bone Turnover 10 Years After a Single 5 mg Dose or Two 5-Yearly Lower Doses of Zoledronate in Osteopenic Older Women: An Open-Label Extension of a Randomized Controlled Trial	2020	https://doi.org/10.1002/jbmr.4453

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically